Many women have a difficult time managing the effects of hormonal changes that accompany the aging body. Many women suffer from known hormonal conditions and symptoms as a result of hormonal imbalances or deficiencies, such as, menopause, endometriosis, osteoporosis, heart disease, cancer in particular breast cancer, hot flashes, night sweats, vaginal dryness, mood changes, and musculoskeletal symptoms. At present, hormonal imbalances and conditions are routinely treated with a variety of hormonal therapies.
In addition, a number of hormonal therapies have been used for purposes of contraception. In particular, compositions that utilize conjugated estrogens and/or a progesterone, such as those sold by Wyeth-Aerst under the name PREMARIN® and PREMPRO® are widely known and used.
It is now known that some estrogen therapies, despite their immediate benefits, may increase the long term incidences of certain life threatening conditions, such as cancer. It is thought that this is due, at least in part, to the abundance of active estrogen metabolites produced by the liver upon administration of traditional estrogens. For example, estradiol is the most biologically active and potent estrogen in the body. Estradiol is most often associated with the growth of breast and reproductive tissues and development of skeletal homeostasis. When estradiol is metabolized, it is first oxidized to estrone and then hydrolulated by 2-hydroxylase and 16-hydroxylase enzymes in the liver. This reaction produces the metabolites of 16-alphahydroxyestrone (active) and 2-hydroxyestrone (inactive).
Indole compounds, specifically indole-3-carbinol compounds are naturally occurring compounds derived from various plant sources, particularly, cruciferous plants such as broccoli, cabbage, turnips and brussel sprouts. Indole-3-carbinol is a member of the glucosinolates chemical group, a sulfur-containing chemical compound. Indole-3-carbinol compounds are antioxidants and have heretofore been primarily recognized as useful for cancer prevention. See, Auborn, Fan, Rosen, Goodwin, Chandraskaren, Williams, Chen and Carter, “Indole-3-Carbinol Is a Negative Regulator of Estrogen,” American Society for Nutritional Sciences (2003). However, there has been some indication that administration of indole-3-carbinol can reduce the amount of active estrogen metabolites resulting from typical estrogen therapy, or from metabolism of endogenous estrogen.
Phytoestrogens are naturally occurring phenolic plant compounds which are found in many food and/or plant sources, such as, beans, cabbage, soybean, grains, and hops. Generally, phytoestrogens are extracted from seeds, stems, flowers and roots of plants and food sources. Phytoestrogens are structurally similar to estrogen and estradiol produced by mammals. For this reason, phytoestrogens can play an important roll in dietary supplementation for subjects suffering from a hormonal imbalance. However, most phytoestrogens are less potent than traditional estrogens and need to be consumed in large quantities in order to have a significant estrogenic effect. It is now also thought that administration of phytoestrogens may also increase production of 2-hydroxyestrone.
In view of the foregoing, compositions and methods which provide an estrogen supplementation benefit and reduce the in-vivo production of active estrogen metabolites continue to be sought.